Microbiota in Urine and Urothelium Can be a Factor for Induction of Urinary Bladder Cancer. The Study Will Examine Urine and Bladder Cancer Tissues From Male Patients and Urine of Controls Using Whole Genomic Sequencing Techniques and 16S rRNA. The Aim is to Elucidate Role of Microbiota in Bladder

NCT06289283 | Active Not Recruiting DMC

• 1 other identifier: Theodor Bilharz Research Ins.
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Microbes inhabiting the urinary tract that are playing an important role in maintenance of health and the development of diseases and bladder cancer. There is correlation between initiation of bladder cancer and microbes. Urine and bladder tissues from healthy individuals and patients with bladder cancer were analyzed using 16S rRNA sequencing, results show abundant phylum. Next-generation sequencing technologies will be applied with whole genomic and 16S ribosomal RNA gene sequencing for microbiota profiling in urine and bladder tissue of male healthy individuals and patients with bladder cancer. Results will lead to prevention, diagnosis and new treatment strategies for bladder cancer.

Conditions

Urinary Bladder Neoplasms; Microtia

Outcome Measures

Primary Outcomes (1)

• To characterize the microbiota in health and bladder cancer, and may lead to new prevention, diagnosis and treatment strategies for bladder cancer

  Biochemestry and molecular biology assessment: 16S Metagenomic Sequencing analysis Whole genomic sequencing (WGS) will be applied to all cases, methodology and quality control are according to the genomic and metagenomic center in the children cancer hospital 57357 who are going to perform the WGS and 16S sequencing on urine and tissue samples. 1- DNA isolation from urine and tissue. Urine specimens (50ml) will be thawed and centrifuged at 7500g, 4°C for 10minutes. The pellet will be used for DNA extraction using Invitrogen™ PureLink™ Microbiome DNA Purification Kit, performed according to manufacturer's protocol. To avoid environmental contamination, all isolations from urine samples and from the reagent-only extraction control will be carried out within a PCR hood. Isolated DNA samples will be placed at -20 °C until PCR amplifcation. DNA will be quantifed using DeNovix dsDNA High Sensitivity Assay Kit (Illumina 2013) . 2- PCR based KABA KAPA Library Quantification Kits contain all

  Sample sollection 12 months, next generation sequencing ind bioinformatics 6 months, interpretation of data 6 months.

Study Arms (1)

Bladder carcinoma of non muscle invasive bladder cancer and muscle invasive bladder cancer.

Group I: Non-muscle invasive bladder cancer,16 patients, 16 for bladder tissue, and 16 for urine samples. Total 32 samples. (The study will explore the microbiota in urine and in tissue samples, so every patient with bladder cancer will give (2 samples). The control group will give urine sample ( one samble). Recent research showed that microbiota is detecred in the urothelium of normal undividuals and patients with bladder cancer, this microbiota would differ from urine( liquid) microbiota.(References: ) Group II: Muscle invasive bladder cancer, 11 patients. 22 samples 11 for bladder tissue and 11 for urine samples obtained from the same patients. Group III: 11 Normal adults: urine samples from serves as control group of the study. Total number of participant is 38 individual

Other: Urine samples and tissue samples: Samples will be collected in clean leak-proof containers without disinfectant or detergent residue and with tight-fitting leak-proof lids and preserved in a refrigera

Interventions

Urine samples and tissue samples: Samples will be collected in clean leak-proof containers without disinfectant or detergent residue and with tight-fitting leak-proof lids and preserved in a refrigera OTHER

Samples for microbiome analysis: Samples will be collected in clean leak-proof containers without disinfectant or detergent residue and with tight-fitting leak-proof lids and preserved in a refrigerator until be analyzed at the microbiology laboratory of TBRI. Urine samples (50 ml) for microbiome analysis will be collected during cystoscopy examination. Samples will be stored at -80 °C until processing. Tissue and urine samples from patients with bladder cancer: Under standard procedure of diagnostic cystoscopy urine sample will be collected under complete aseptic conditions, patients who has bladder tumor will undergo transurethral resection of bladder tumor, a tissue sample 0.5x0.5 cm will be investigated for microbiome analysis. Samples will be stored at -80 °C until processing. Histopathological diagnosis with Hematoxylin and eosin stain will be done by an expert pathologist for tumor grade and stage according to WHO 22, and EAU guidelines 2023. This procedure will be applied for

Bladder carcinoma of non muscle invasive bladder cancer and muscle invasive bladder cancer.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Group I: Non-muscle invasive bladder cancer,16 patients, 16 for bladder tissue, and 16 for urine samples. Total 32 samples. (The study will explore the microbiota in urine and in tissue samples, so every patient with bladder cancer will give (2 samples). The control group will give urine sample ( one samble). ) Group II: Muscle invasive bladder cancer, 11 patients. 22 samples 11 for bladder tissue and 11 for urine samples obtained from the same patients. Group III: 11 Normal adults: urine samples from serves as control group of the study. Total number of participant is 38 individual.

You may qualify if:

• Adult men above 18 years,
• Diagnosed of carcinoma of the bladder with imaging ultrasonography and/ or computerized tomography, and urine cytology.
• Confirmed bladder cancer either during diagnostic cystoscopy, previous pathology, or pathological examination of the biopsy specimens.

You may not qualify if:

• Previous radiotherapy to the bladder or to adjacent organ.
• Previous intravesical instillation immunotherapy with bacillus Calmette-Guérin (BCG), or intravesical instillation of chemotherapeutics.
• Previous neoadjuvant chemotherapy.

Sponsors & Collaborators

• Theodor Bilharz Research Institute: lead

Study Sites (1)

Theodor Bilharz Research Institute

Cairo, 12411, Egypt

Location

Related Publications (1)

• Whiteside SA, Razvi H, Dave S, Reid G, Burton JP. The microbiome of the urinary tract--a role beyond infection. Nat Rev Urol. 2015 Feb;12(2):81-90. doi: 10.1038/nrurol.2014.361. Epub 2015 Jan 20.

  PMID: 25600098 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Urine samples and tissue samples of bladder.

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Congenital Microtia

Interventions

Disinfectants; Preservation, Biological

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Therapeutics; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor

Study Record Dates

• First Submitted: February 25, 2024
• First Posted: March 1, 2024
• Study Start: October 12, 2023
• Primary Completion: April 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)